Identification of Predictive Factors for Survival of Patients With Recurrent Prostate Cancer From Clinical Features, Tissue Image Features and Molecular Biomarker Data

This study has been completed.
Sponsor:
Collaborators:
Aureon Biosciences, Inc.
NYU MEDICAL CENTER
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00578409
First received: December 19, 2007
Last updated: April 27, 2010
Last verified: April 2010
  Purpose

We seek to improve the predictive accuracy of the nomogram to predict survival for patients with castrate mets disease through the addition of pathological data, the results of automated machine vision based image analysis of H&E stained tumor tissue developed at Aureon Biosciences,and molecular biomarker studies (25 markers) determined by immunohistochemistry on tissue microarrays prepared from paraffin-embedded tumor.


Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Identification of Predictive Factors for Survival of Patients With Recurrent Prostate Cancer From Clinical Features, Tissue Image Features and Molecular Biomarker Data

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • The analysis for the progressive castrate mets disease population consists of two analytical steps. The first step involved the development of a predictive model of pt survival using supervised multivariate analytical (SMA)techniques [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

In a first analytical step, using only the clinical and pathological variables used in the original clinical mets castrate disease nomogram as inputs, supervised multivariate analytical techniques (SMA) were used to generate a new predictive model for patient survival. A similar approach will then be used to analyze a second group of approximately 223 pts in the state of a rising PSA14 after surgery or radiation therapy treated on a sequential series of IRB approved trials testing conjugate vaccines also consented on IRB protocol 90-40.


Estimated Enrollment: 0
Study Start Date: May 2004
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Stage 1 - Population: Progressive Metastatic Disease Stage 2 - Population: Rising PSA

Criteria

Inclusion Criteria:

Patients in the first retrospective study (Stage 1) must be part of the 409 patient strong MSKCC cohort with progressive metastatic prostate cancer which was used for the generation of the original nomogram.

For details please see original publication by Smaletz et al. Patients involved in the second retrospective study (Stage 2) must be part of the 223 patients with a rising PSA after surgery or radiation therapy who were treated on conjugate vaccine trials at MSKCC..

Exclusion Criteria:

For details of excluded patients on the clinical metastases castrate disease study, please see original publication by Smaletz et al.4

• (MSKCC - add reference if publication available for rising PSA patients)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00578409

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Aureon Biosciences, Inc.
NYU MEDICAL CENTER
Investigators
Principal Investigator: Howard I Scher, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Howard I. Scher, MD, Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00578409     History of Changes
Other Study ID Numbers: 04-062
Study First Received: December 19, 2007
Last Updated: April 27, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
castration resistant prostate cancer
progressive castrate metastatic prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 26, 2014